Hallux valgus repairs using suture-button construct

ABSTRACT

A technique and associated instrumentation for correcting large intermetatarsal angles that result from hallux valgus. The system includes a button and a suture loop attached to the button. A suture strand is threaded through holes in the button to attach the button to the suture. The suture ends are then brought together (by being swaged, spliced or cinched together, for example) to form the suture loop comprising a continuous, uninterrupted suture loop with a single strand of swaged-together ends. The swaged-together ends may be attached to a suture passing instrument such as a K-wire (Kirschner wire) that may be further used to drill a hole through the first and second metatarsals. The swaged-together ends of the suture are then passed through the drill holes in the first and second metatarsals; and the ends of the suture are pulled until the button abuts the second metatarsal. The swaged together portion of the suture loop is then cut, and the free suture ends are passed through holes in another (second) button. The suture ends are pulled to adjust the first metatarsal to a correct intermetatarsal angle, and the first metatarsal is secured in place by tying the ends of the suture together against the second button.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/314,015, filed Mar. 15, 2010, the entire disclosure of which isincorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to the field of surgery and, inparticular, to a bunion repair technique using a suture-button constructand to a device.

BACKGROUND OF THE INVENTION

Hallux valgus, more commonly known as bunions, is a condition where thefirst metatarsal deviates inward toward the second metatarsal. Thisresults in an intermetatarsal angle that is too large. Bunions arecaused when certain tendons, ligaments, and supportive structures of thefirst metatarsal no longer function correctly causing the firstmetatarsal to be misaligned. Bunions may be caused by a variety ofconditions intrinsic to the structure of the foot, such as flat feet,excessive ligamentous flexibility, abnormal bone structure, and certainneurological conditions.

Bunions are commonly associated with arthritis of the first metatarsal,diminished and/or altered range of motion and discomfort when pressureis applied to the first metatarsal or with motion of the joint.Treatments of bunions vary and, depending on severity of themisalignment, can range from rest, medication, orthotics and, in extremecases, surgery.

Numerous techniques have been used during surgery to correct theintermetatarsal angle, including the reshaping or removal of part of thefirst metatarsal bone. Other techniques have also been used to reducethe intermetatarsal angle to a normal angle of less than 9° to 11°. Oneway to reduce the intermetatarsal angle is by connecting the first andsecond metatarsals together with a suture, to secure the firstmetatarsal at a proper angle.

One such technique for hallux valgus repairs employs a suture-buttonconstruct as detailed in U.S. Patent Publ. No. 2008/0208252 (filed onJan. 17, 2008 and assigned to Arthrex, Inc.). According to U.S. PatentPubl. No. 2008/0208252, a suture strand is double looped through firstand second buttons, and a pull-through suture is attached to one of thebuttons and to a needle. This technique requires one large diameterhole, drilled through both the first and second metatarsals, to allowpassage of the button.

Another technique employs a deconstructed suture-button construct soldby Arthrex, Inc. of Naples, Fla. under the tradename Mini TightRope®.The deconstructed Mini TightRope® technique involves drilling two smalldrill holes through the first and second metatarsal, and passing suturesthrough each hole, thereby connecting the first and second metatarsals.This procedure requires a higher degree of technical difficulty,however, since both drill holes must be parallel and in the same plane.What is needed is a simpler technique but with equivalent strength. Alsoneeded is a technique that requires only one small hole in lieu ofmultiple holes drilled through the first and second metatarsals.

BRIEF SUMMARY OF THE INVENTION

The present invention provides systems and methods for correcting largeintermetatarsal angles that result from hallux valgus. The systemincludes a button and a suture loop attached to the button. According toan exemplary embodiment, a suture strand is woven through holes in thebutton to attach the button to the suture. The suture ends are thenbrought together (by being swaged, spliced or cinched together, forexample) to form the suture loop comprising a continuous, uninterruptedsuture loop and a single strand of swaged-together ends attached to theloop. The swaged-together ends may be attached to a suture passinginstrument such as a K-wire (Kirschner wire) that may be further used todrill the hole.

A method for correcting intermetatarsal angles that result from halluxvalgus employing the suture-button construct of the present invention(with a continuous suture loop attached to a button) includes inter aliathe steps of: (i) providing a suture construct attached to a button byswaging or cinching together ends of a suture strand woven through holesof the button to form a button/suture loop system; (ii) passing theswaged-together ends of the suture through drill holes in the first andsecond metatarsals; (iii) pulling the ends of the suture until thebutton abuts the second metatarsal; (iv) removing (by cutting, forexample) the swaged together portion of the suture; (v) attaching thesuture ends to another (second) button; and (vi) adjusting the firstmetatarsal to a correct intermetatarsal angle, and securing the firstmetatarsal in place by the suture-button construct and the secondbutton.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a schematic perspective view of an oblong buttonwhich forms part of the suture-button construct of the presentinvention;

FIG. 2 illustrates an embodiment of a suture-button construct of thepresent invention;

FIG. 3 illustrates a schematic view of a patient's foot with a halluxvalgus repair according to a first embodiment of the present invention(and illustrating the suture-button construct of the present inventionand another button, one each against the first and second metatarsals).

FIG. 4 illustrates a schematic view of a patient's foot with a halluxvalgus repair according to a second embodiment of the present invention.

FIGS. 5-12 illustrate subsequent steps of a method of correctingproblems associated with hallux valgus employing the suture-buttonconstruct of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates button 120 used in corrective surgery for halluxvalgus. Button 120 is an oblong shaped plate with chamfered or roundedcorners and edges. Button 120 has a length that extends from proximalend 125 to distal end 126. Button 120 further has a width that isshorter than the length. Button 120 also has front face 127 and backface 128, wherein the distance between the front and back face 127, 128is smaller than the width of button 120. In another embodiment, thedistance between front and back face 127, 128 is greater than the widthof button 120.

Button 120 further includes holes 122 and 124 that extend from frontface 127 to back face 128. Hole 122 is located near distal end 126. Hole124 is located near proximal end 125. Holes 122 and 124 are ofsufficient diameter to allow suture 110 to pass through, but not solarge as to severally compromise the integrity and strength of button120.

FIG. 2 illustrates suture-button construct 200 (attachment 200) thatincludes a suture 110 and a button 120. Suture 110 is a threadlikematerial that is commonly employed in surgery to hold tissue or bonetogether. In this embodiment, suture 110 is #2 FiberWire® from Arthrex.In other embodiments, different types of sutures and different sizes ofsutures may be used.

As shown in FIG. 2, suture 110 passes through first hole 122 of button120 and through second hole 124. As a result, suture 110 includes firstleg 112 that passes through hole 122 and extends away from back face 128and second leg 114 that passes through hole 124 and also extends awayfrom back face 128. Suture 110 also includes connecting leg 113 thatextends between first hole 122 and second hole 124 along front face 127of button 120.

In suture-button construct 200, first leg 112 and second leg 114 ofsuture 110 are swaged together to form combined leg 116 (single tail116) of suture 110. As a result, part of suture 110 is formed into acontinuous, uninterrupted loop with the loop portion of suture 110passing through holes 122 and 124 of button 120.

A method of conducting surgery to reduce the intermetatarsal angle byfixating the first metatarsal using suture-button construct 200(attachment 200) is now described. Preparation for an exemplary surgicaltechnique relies upon radiographic film, surgical templates, and trialimplants to determine and select the appropriate combination of suture110 and button 120 that meets the patient's anatomical requirements.

FIGS. 3 and 4 illustrate final hallux valgus repairs with thesuture-button construct 200 (attachment 200) of the present invention.Referring to FIG. 3, in a first embodiment of the invention, a surgeondrills a hole using a suture passing K-wire through first metatarsal 310and second metatarsal 320, drilling from second metatarsal 320 to firstmetatarsal 310. Suture-button construct 200 is loaded on the K-wire withcombined leg 116 of suture 110 attached to the K-wire. Combined leg 116of suture 110 is shuttled completely through the holes in firstmetatarsal 310 and second metatarsal 320 by the K-wire. Suture 110 thencontinues to be shuttled through until button 120 of attachment 200rests against the lateral cortex of second metatarsal 320.

With button 120 resting against second metatarsal 320, first leg 112 andsecond leg 114 of suture 110 will have been shuttled through the holesin first metatarsal 310 and second metatarsal 320. First and second legs112, 114 of suture 110 are then cut from combined leg 116, leaving firstand second legs 112, 114 protruding from the hole in first metatarsal310.

A second button 350 (for example, a round or oblong button 350) is thenplaced over first and second legs 112, 114 protruding from the hole infirst metatarsal 310. First and second legs 112, 114 of suture 110should be of sufficient length to extend through both the first andsecond metatarsals 310, 320 and allow for the surgeon to comfortable tiefirst and second legs 112, 114 over the top of second button 350. Thesurgeon then adjusts first metatarsal 310 to achieve a properintermetatarsal angle. First metatarsal is secured in place by tyingdown second button 350 in standard fashion as shown in FIG. 3. In thismanner, suture-button construct 200 in combination with second button350 secures first metatarsal 310 at a proper intermetatarsal angle.

In an alternative embodiment, a similar method is used but in reverseorder. In this embodiment, with the final step shown in FIG. 4, asurgeon drills a hole using a suture passing K-wire (in a method similarto the one described above), but drilling from first metatarsal 310 tosecond metatarsal 320. Suture-button construct 200 is loaded on theK-wire and combined leg 116 of suture 110 is shuttled through the holesin first metatarsal 310 and second metatarsal 320 by the K-wire. Suture110 is shuttled through the holes in first metatarsal 310 and secondmetatarsal 320 until button 120 rests against the medial cortex of firstmetatarsal 310. First and second legs 112, 114 of suture 110 are cutfrom combined leg 116. First metatarsal 310 is correctly positioned andsecond button 350 is placed over first and second legs 112, 114 and tieddown in standard fashion between second metatarsal 320 and thirdmetatarsal 330 to secure first metatarsal 310.

FIGS. 5-12 illustrate in detail the steps of a method of correctingproblems associated with hallux valgus employing the suture-buttonconstruct 200 of the present invention.

FIG. 5: For the distal approach, the first interspace release isperformed through the incision made between the distal first and secondmetatarsals 310, 320. A dorsal medial and medial incision can also beused with appropriate distraction of soft tissues.

FIG. 6: To realign the fibular sesamoid, the adductor tendon is detachedfrom both the base of the proximal phalanx and the fibular sesamoid. Thedeep intermetatarsal ligament and lateral capsule are released. Anysesamoid adhesions to the intermetatarsal ligament are freed.

FIG. 7: The medial capsule is incised, exposing the entire medialeminence. The medial eminence is removed, preserving the sesamoid grooveon the plantar aspect of the first metatarsal 310.

FIG. 8: The second lateral metatarsal 320 is exposed for placement ofthe construct 200 of the present invention. The first metatarsal 310 isreduced with provisional fixation to the second metatarsal 320. A C-armis used to assure proper placement of a suture passing instrument 313(for example, a 1.1 mm tapered Suture Passing K-wire 313) at the centerof the second metatarsal shaft, about 2-3 mm proximal to the neck of thesecond metatarsal 320. The second metatarsal 320 is elevated and exposedwith an elevator (for example, a Freer Elevator) and a small rakeretractor (soft tissue) prior to K-wire insertion. The suture passingK-wire 313 is passed from the second metatarsal 320 through the firstmetatarsal 310, in the direction of arrow A. The wire should exit justproximal to the excised medial eminence. For accurate placement of theK-wire 313, the drill angle should be modified as shown in FIG. 8( a).

FIG. 9: With the first metatarsal 310 manually reduced, the suturepassing K-wire 313 is positioned so that the tapered portions just exitthe medial cortex of the first metatarsal 310 (where the pointed end ofarrow B intersects the cortex of the first metatarsal 310). This willallow easy passage of the suture loop (#2 FiberWire) through the drillhole 314.

FIG. 10: Prefabricated loop 110 and leg 116 of the suture-buttonconstruct 200 is fed through the loop 313 a (Nitinol loop portion 313 a)of the K-wire 313. The suture passing K-wire 313 is pulled medially,passing the free end 116 of the suture construct 200 through the 1.1 mmpilot hole 314.

FIG. 11: After the suture of construct 200 has been passed from lateralto medial, the swaged portion (combined leg 116) is cut and the ends ofthe #2 FiberWire 112, 114 are rethreaded through opposite holes in asecond button 350 (for example, an oblong button). If a round button isused, the button is threaded in the same way using opposite holes.

FIG. 12: If two constructs 200, 200 a are employed for the repair, thefirst of two suture-button constructs 200, 200 a is tied down with oneknot while the second construct 200, 200 a is placed about 5-7 mmproximal from the first construct. The second construct 200 a is placedin a manner similar to that for the placement of construct 200 (detailedabove) with same drilling and passing instructions. FIG. 12 illustratessuture-button constructs 200, 200 a in combination with second buttons350, 350 a securing first metatarsal 310 at a proper intermetatarsal(IM) angle. The IM angular correction on the C-arm is checked prior tothe final tightening, preferably using three knots on button 350, 350 afor closure. FIG. 12( a) illustrates an X-ray depiction of the finalconstruct of FIG. 12.

FIGS. 10( a)-(d) illustrate subsequent steps that are optional to thestep illustrated in FIG. 10, i.e., instead of positioning the sutureknots on the medial side of the first metatarsal 310, the knot(s) areplaced lateral to the second metatarsal 320, as detailed below.

FIG. 10 a: One limb of a passing suture 315 (for example, a 2-0FiberWire suture 315) is passed from lateral to medial through thedistal hole using the suture passing K-wire 313 with Nitinol loop 313 a(in the direction of arrow A).

FIG. 10 b: Making sure to hold onto the free ends of the suture 315lateral to the second metatarsal 320, the suture passing K-wire 313 isremoved. The free end 116 of suture-button construct 200 is threadedthrough closed end 315 a of the passing suture 315. The construct 200 ispulled from medial to lateral back through the hole. The loop 315 a willact as a suture shuttle, pulling the suture-button construct 200 frommedial to lateral.

FIG. 10 c: The passing suture 315 is removed. The construct can now becompleted with a second button 350 and at least one knot (preferablythree knots) lateral to the second metatarsal 320.

FIG. 10 d: The final construct is illustrated with a knot 350 a tiedover the second button 350 on the lateral aspect of the secondmetatarsal 320.

The attachment system of the present invention has the same strength asthe deconstructed Mini TightRope® from Arthrex, but reduces time in theoperating room, requires only one drilled hole in lieu of multiplesholes, makes the overall operation less challenging, and allows patientsto return to full activities faster.

Although the present invention has been described in relation toparticular embodiments thereof, many other variations and modificationsand other uses will become apparent to those skilled in the art.Therefore, the present invention is to be limited not by the specificdisclosure herein, but only by the appended claims.

1. A fixation system, comprising a button/loop construct having a buttonwith at least a pair of apertures designed to allow passage of aflexible strand, and a loop construct connected to the button, the loopconstruct comprising a continuous uninterrupted loop of a flexiblestrand, with both opposing ends of the flexible strand terminating in asingle strand.
 2. The fixation system of claim 1, wherein the flexiblestrand is a suture strand.
 3. The fixation system of claim 2, whereinthe suture strand comprises a plurality of fibers of ultrahigh molecularweight polyethylene.
 4. The fixation system of claim 1, wherein the loophas a fixed length.
 5. The fixation system of claim 1, wherein the loopand the single strand have a combined length greater than a sum of awidth of a first metatarsal, a width of a second metatarsal, and adistance between the first and second metatarsals.
 6. The fixationsystem of claim 1, wherein both opposing ends are swaged or cinchedtogether to form the single strand.
 7. The fixation system of claim 1,wherein the single strand is formed by splicing both opposing ends ofthe flexible strand.
 8. The fixation system of claim 1, wherein thebutton has two apertures and the loop passes through the two apertures.9. A suture-button construct, comprising: a suture strand; and a buttonhaving a pair of apertures, the apertures being designed to allowpassage of the suture strand; and wherein the suture strand is loopedthrough the apertures of the button, and wherein both free legs of thesuture strand are brought together to form a combined leg.
 10. Thesuture-button construct of claim 9, wherein the suture strand comprisesa plurality of fibers of ultrahigh molecular weight polyethylene. 11.The suture-button construct of claim 9, wherein the button is made of amaterial comprising one of titanium, stainless steel, PEEK, or PLLA. 12.The suture-button construct of claim 9, wherein the button issubstantially oblong-shaped with chamfered or rounded corners and edges.13. The suture-button construct of claim 9, wherein the free legs of thesuture strand are cinched or swaged together to form the combined leg.14-19. (canceled)